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CTRI Number  CTRI/2023/12/060820 [Registered on: 27/12/2023] Trial Registered Prospectively
Last Modified On: 23/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   self-esteem and quality of life among patients with chronic skin diseases. 
Scientific Title of Study   A study to assess the self-esteem and quality of life among patients with chronic skin diseases attending dermatology unit of selected hospitals of Udupi district, Karnataka. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  LEENA CHETRY 
Designation  Student 
Affiliation  Manipal college of nursing 
Address  Manipal college of nursing, MAHE, Manipal, Udupi Karnataka

Udupi
KARNATAKA
576104
India 
Phone  7629884096  
Fax    
Email  leenachetry865@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  LEENA CHETRY 
Designation  Student 
Affiliation  Manipal college of nursing 
Address  Manipal college of nursing, MAHE, Manipal, Udupi Karnataka

Udupi
KARNATAKA
576104
India 
Phone  7629884096  
Fax    
Email  leenachetry865@gmail.com  
 
Details of Contact Person
Public Query  
Name  Melita Sheilini 
Designation  Assistant professor 
Affiliation  Manipal college of nursing 
Address  Manipal college of nursing
Manipal college of nursing, MAHE, Manipal, Udupi Karnataka
Udupi
KARNATAKA
576104
India 
Phone  8095976561  
Fax    
Email  shyli.mel@manipal.edu  
 
Source of Monetary or Material Support  
Manipal college of nursing, MAHE, Manipal 
 
Primary Sponsor  
Name  LEENA CHETRY 
Address  Manipal college of nursing, MAHE, Manipal, Udupi Karnataka 
Type of Sponsor  Other [self sponsor] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Leena chetry  Kasturba Hospital, Manipal  Department of dermatology, Kasturba hospital, MAHE, Manipal, Udupi Karnataka
Udupi
KARNATAKA 		 7629884096

leenachetry865@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L309||Dermatitis, unspecified, (2) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  •The patients age should be 18 years and above.
•Patient must be diagnosed with chronic skin disease for minimum six month or more (psoriasis, acne vulgaris, chronic dermatitis, chronic urticaria, chronic hair disorders, vitiligo, autoimmune connective disorders, auto immune blister disorders) and undergoing treatment.
•Patients who are willing to participate
•Patients who know English Kanada.
 
 
ExclusionCriteria 
Details  •Patients below the age of 18 years
•Patient who does not know english or kanada

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Self esteem  self esteem 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life  quality of life 
 
Target Sample Size   Total Sample Size="480"
Sample Size from India="480" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [leenachetry865@gmail.com].

  6. For how long will this data be available start date provided 15-09-2024 and end date provided 15-09-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Study will be conducted after obtaining appropriate permission in the dermatology unit of Kasturba Hospital Manipal. The participants will be explained about the study and their participation in the research. Samples are selected using a purposive sampling technique. To assess the self-esteem and quality of life among the chronic skin disease patient quantitative survey approach will be used. The researcher has adopted descriptive survey. After obtaining the necessary administrative permission and CTRI registration, the data will be collected by administering the tools to the participants. Informed consent will be taken from the participants prior to the data collection and confidentiality of the data will be maintained.

The data collection for background information will be collected by using:

a)     Demographic Proforma- Age, gender, religion, marital status, education, occupation, place of residence, type of family and family income.

b)     Clinical Proforma- anthropometric measurement, medical history, compliance to medication, response to medication, past medical history, history of substance abuse

The background information will be collected when the patients come to the dermatology OPD for follow up. The self-esteem and quality of life among the chronic skin disease patient will be assessed by the standardized tools that is Rosenberg self-esteem and dermatology index of quality of life.

 
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